Effects of Photobiomodulation With Red and Infrared Low-level Laser Diodes in Individuals Undergoing Rhinoplasty at a Single Centre: Protocol for a Randomized, Double-blind, Controlled Clinical Trial

What this Trial Is About

Researchers are evaluating the effects of preoperative photobiomodulation (PBM) using red and infrared light on reducing early postoperative swelling around the eyes in patients undergoing primary open rhinoplasty with piezo-assisted osteotomies. This randomized, double-blind, sham-controlled trial includes 60 participants and aims to measure periorbital edema on the third day after surgery using a clinical scale with standardized photos. Secondary outcomes include bruising, pain levels, pain medication use, nasal tip skin thickness, and patient-reported functional and aesthetic results, with follow-up lasting up to 12 months. Participants will be randomly assigned to receive either active PBM or a sham PBM procedure one hour before surgery. Both groups will undergo the same standardized surgical technique and perioperative care, including specific medications during and after surgery. The active treatment uses a device emitting red (660 nm) and infrared (808 nm) light, while the sham group receives an inactive device application designed to maintain blinding. During the study, participants will have assessments of swelling and bruising at multiple time points up to 12 months post-surgery, including photographic documentation and digital image analysis. Other evaluations include pain measurements, skin thickness, medication use, and patient feedback on function and aesthetics. Safety will be monitored throughout, and all data will be collected according to strict protocols to ensure consistency and reliability.

Effects of Red and Infrared Photobiomodulation in Rhinoplasty at a Single Centre